Diagnosis and Drug Monitoring in Bleeding Disorders: 2016 and Beyond

This activity has expired.
Release Date: August 12, 2016
Expiration Date: August 12, 2017
Estimated Time to Complete Activity: 1.25 hours
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Target Audience
This activity is targeted toward hematologists, nurse practitioners (NPs), nurses, physician assistants (PAs), laboratory scientists, and other healthcare professionals interested in the care of patients with hemophilia.

Statement of Need/Program Overview
The challenges in diagnosing and monitoring bleeding disorders lie in the sensitivity of the tests, the complicated algorithms for investigating and interpreting results, the potential for assay discrepancy and inaccuracy, and intra- and inter-laboratory variability. Predicting and monitoring patient response to factor replacement products is equally challenging, and traditional diagnostic assays do not always provide adequate information regarding the hemostatic activity of these agents. All of these issues increase the risk of misdiagnosis or suboptimal management.

This free 1.25 hour CME/CNE-certified activity will provide an overview of standard and global assays to help the interprofessional care team gain a broader understanding of the different assay types, assay components, reagents and instruments. The faculty will use case scenarios to outline the benefits and limitations of the different assays and offer insights on how to prevent errors and improve diagnostic accuracy. Additionally, the expert faculty will describe strategies for hemostatic monitoring of novel factor therapies and the implications of assay results for patients and their families.

Educational Objectives
After participating in this activity, participants should be better able to:
  • Review recent advances in the scientific understanding of hemostasis and the mechanisms by which hemostatic therapies work to counteract bleeding disorders
  • Summarize factors that can negatively affect the accuracy of hemostatic assays for the diagnosis and monitoring of bleeding disorders
  • Outline the benefits and limitations of investigational methods of assessing hemostasis, including global hemostatic assays and chromogenic assays
  • Describe how novel factor replacement therapies may impact standard practice for hemostatic monitoring
Presenting Faculty
Rajiv K. Pruthi, MBBS [Chair]
Associate Professor of Medicine
Mayo Medical School
Director, Mayo Special Coagulation Laboratory and Coagulation Programs
Mayo Clinic
Rochester, MN

Maureane R. Hoffman, MD, PhD
Professor of Pathology
Assistant Professor of Immunology
Department of Pathology, Division of General Pathology
Duke University
Durham, NC

James Munn, BS, BSN, MS
Program and Nurse Coordinator
University of Michigan Hemophilia and Coagulation
Disorders Program
Ann Arbor, MI

Physician Continuing Medical Education
Accreditation Statement
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of American Academy of CME, Inc., (Academy) and E&S MedEd Group, Inc. American Academy, Inc., is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation
American Academy of CME, Inc., designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Continuing Education
Accreditation Statement
American Academy of CME, Inc., is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

Credit Designation
American Academy of CME, Inc., designates this educational activity for 1.25 contact hours
(1.0 pharmacotherapeutic contact hours).

Method of Participation
During the period of August 12, 2016 through August 12, 2017, participants must:
  • Read the learning objectives and faculty disclosures
  • Study the educational activity
  • Complete the posttest by recording the best answer to each question
  • Complete the evaluation form
A statement of credit will be issued automatically upon successfully completing the post-activity survey with a score of 70% or better and submitting the activity evaluation.

Fee Information
There is no fee for this educational activity.

Disclosure of Conflicts of Interest
According to the disclosure policy of the Academy, all faculty, planning committee members, editors, managers and other individuals who are in a position to control content are required to disclose any relevant relationships with any commercial interests related to this activity. The existence of these interests or relationships is not viewed as implying bias or decreasing the value of the presentation. All educational materials are reviewed for fair balance, scientific objectivity and levels of evidence.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:

Name of Faculty or Presenter Reported Financial Relationship
Rajiv K. Pruthi, MBBS Dr. Pruthi states that he has no relevant financial relationships to disclose.
Maureane R. Hoffman, MD, PhD Dr. Hoffman states that she is on the Advisory Board for scientific information for Hemosonics, Vital Therapies, and Chimera Biotech.
James Munn, BS, BSN, MS Mr. Munn discloses that he serves on the Advisory Board for marketing purposes and scientific information for Baxalta; Biogen-Idec; CSL Behring; Emergent BioSolutions; Novo Nordisk; and Pfizer. He is a Consultant for marketing purposes for Bayer and Emergent BioSolutions. He is also on the Promotional Speaker’s Bureaus for Biogen-Idec, Emergent BioSolutions, and Novo Nordisk.

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:

Name of Planner or Manager Reported Financial Relationship
Laurie Ermentrout; John JD Juchniewicz, MCIS, CHCP; Lisa Kehs and Natalie Kirkwood, RN, BSN, JD (Lead Nurse Planner) State that they have no relevant financial relationships to disclose
Anu Hosangadi, MS Anu Hosangadi, MS, states that both she and her spouse own stock in Biogen, Bristol-Myers Squibb, Celgene, Gilead Sciences, Johnson & Johnson, Merck & Co., Novo Nordisk.


Disclosure of Unlabeled Use
The activity will discuss off-label use of assays and devices for monitoring hemostatic factor replacement.

The opinions expressed in this educational activity are those of the faculty, and do not represent those of the Academy, E&S MedEd Group or American Nurses Credentialing Center’s Commission on Accreditation. This activity is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically, and draw conclusions only after careful consideration of all available scientific information.

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© 2016. This CME/CNE-certified activity is held as copyrighted © by American Academy of CME and E&S MedEd Group. Through this notice, the Academy and E&S MedEd Group grant permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).